Guidance on the Inventory of Select Agents and Toxins: Regulatory Definitions that Apply to this Document

Biological Agent – Any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsia, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or other living organism, deterioration of food, water, equipment, supplies, or material of any kind, deleterious alteration of the environment.

Toxin – Toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substances, or recombinant or synthesized molecules, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism, or any poisonous isomer or biological product, homolog, or derivative of such a substance.

Recombinant Nucleic Acids – (1) Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell or (2) molecules that result from the replication of those described in (1) above.

Synthetic Nucleic Acids – (1) Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules or (2) or molecules that result from the replication of those described in (1) above.